Less than three months af­ter Bay­er re­leased pos­i­tive Phase III da­ta for a top pro­gram, the FDA has agreed to take up its case.

Reg­u­la­tors have grant­ed pri­or­i­ty re­view for finerenone, an ex­per­i­men­tal drug in pa­tients with chron­ic kid­ney dis­ease and type 2 di­a­betes, Bay­er an­nounced Tues­day. Bay­er did not un­veil an ex­pect­ed PDU­FA date but not­ed the FDA would like­ly give finerenone a typ­i­cal six-month look-over.

“Based on study da­ta, finerenone of­fers a po­ten­tial new strat­e­gy to de­lay CKD pro­gres­sion, while re­duc­ing the risk of car­dio­vas­cu­lar events,” Bay­er CMO Michael De­voy said in a state­ment. “We’re en­cour­aged that the FDA has grant­ed the NDA a pri­or­i­ty re­view.”

The de­ci­sion comes fol­low­ing the pro­gram’s Phase III tri­al in which it showed a sta­tis­ti­cal­ly sig­nif­i­cant de­lay in CKD, for both the dis­ease it­self and CKD re­lat­ed to type 2 di­a­betes. Look­ing for a sus­tained de­crease of es­ti­mat­ed glomeru­lar fil­tra­tion rate greater than or equal to 40% from base­line, or re­nal death, finerenone cut risk by 18% over a pe­ri­od of at least four weeks.

That amount­ed to a sparkling p-val­ue of p=0.0014. Bay­er al­so fol­lowed up on pa­tients for a me­di­an of 2.6 years as finerenone was added to the high­est-tol­er­at­ed dose of stan­dard treat­ment.

Bay­er al­so hit on an im­por­tant sec­ondary end­point, de­spite com­ing clos­er to miss­ing than the pri­ma­ry. Finerenone re­duced the risk by 14% in time to car­dio­vas­cu­lar death, non-fa­tal my­ocar­dial in­farc­tion, non-fa­tal stroke or hos­pi­tal­iza­tion for heart fail­ure com­pared to place­bo, amount­ing to a p-val­ue of p=0.03391.

The can­di­date is a non-steroidal min­er­alo­cor­ti­coid re­cep­tor in­hibitor, look­ing to tamp down on what re­searchers found is a trig­ger for both in­flam­ma­tion and fi­bro­sis. Bay­er the­o­rized finerenone could pro­vide more ben­e­fit in stop­ping fi­bro­sis while lim­it­ing in­flam­ma­tion in the heart and kid­neys.

Though there are quite a few CKD drugs out there, CKD pa­tients of­ten ex­pe­ri­ence mul­ti­ple drug fail­ures due to ad­verse events, In­di­ana Uni­ver­si­ty School of Med­i­cine pro­fes­sor Ra­jiv Agar­w­al told End­points News in Oc­to­ber. While finerenone has a short­er half-life than most, al­low­ing it to be ex­punged from the body more quick­ly, the pro­gram saw a high­er rate of events re­lat­ed to high potas­si­um lev­els, af­fect­ing 18% of the drug arm com­pared to half that in the con­trol.

An ap­proval would mark a win for the Ger­man phar­ma af­ter a few tu­mul­tuous years in R&D. Bay­er cut 900 R&D jobs back in No­vem­ber 2018 as part of a broad­er re­struc­tur­ing plan in the wake of its ac­qui­si­tion of Mon­san­to, but more re­cent­ly has be­gun a push in­to gene and cell ther­a­pies. The phar­ma bought out AskBio for $4 bil­lion in Oc­to­ber and, in De­cem­ber, es­tab­lished a cell and gene ther­a­py plat­form with­in its phar­ma­ceu­ti­cals di­vi­sion in or­der to con­sol­i­date all of its re­lat­ed projects un­der one um­brel­la.

The firehose of biopharma news is gushing these days.

That’s why broader and deeper is the theme for 2021 at Endpoints. You can expect new coverage outside our core R&D focus, with deeper reporting in some key areas. When John Carroll and I launched Endpoints nearly five years ago, we were wading in waist-high waters. Now we’re a team of 25 full-time staffers (and growing) with plans to cover the flood of biopharma news, Endpoints-style.

Getting a foot in the door in Boston’s bustling biopharma hub is a rite of passage for many companies, but it comes with a steep price tag. Lithuanian CDMO Northway — now with a new moniker — will set up a new plant in close proximity, and it’s hoping its biologics focus will find a willing customer base.

Northway Biotech (formerly Northway Biotechpharma) on Wednesday held a virtual grand opening ceremony for its $40 million Waltham, MA facility — a 30,000 square-foot cGMP manufacturing and process development plant that will widely expand on the company’s previous capabilities.

The wave of biotech IPOs we’ve been seeing in the last few days underscores that the public markets remain one of the key channels for fresh investments in drug R&D. And that trend was in full view this week as a slate of biotechs nailed down hundreds of millions of dollars in fresh funds.

One of the big winners of the week is Editas $EDIT, which nailed $231 million to back its pioneering work on a gene editing platform. The biotech sold 3.5 million shares at $66 each.

It’s time for a new FDA commissioner to come on board, a rite of passage for Joe Biden’s administration that should help seal the new president’s rep on seeking out the experts to lead the government over the next 4 years.

As of now, the competition for the top job appears to have narrowed down to 2 people: The longtime CDER chief Janet Woodcock and Joshua Sharfstein, the former principal deputy at the FDA under Peggy Hamburg. Both were appointed by Barack Obama.